What adverse events are health care providers required to report?
The Vaccine Adverse Events Reporting System (VAERS), operated by the Food and Drug Administration (FDA) and the CDC, should be notified of any adverse event by completing a VAERS reporting form. The following events are required to be reported: a. Any event set forth in the Vaccine Injury Table that occurs within the time period specified, or within 7 days if that is longer. b. Any contraindicating event listed in the manufacturer’s package insert. In addition, VAERS accepts all reports by any interested party of real or suspected adverse events occurring after the administration of any vaccine. The VAERS form may be obtained by calling 1-800-822-7967. Please note: Submitting a reporting form to VAERS is not the same as filing a claim under the VICP as they are two separate programs.
